Horizontal Ridge Augmentation With Demineralized Bone Allograft Layered With Xenograft - a Prospective Clinical Study

NCT06342973 | Completed Phase 4 FDA Device

• 1 other identifier: 5591
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this case series is to evaluate the outcomes of horizontal ridge augmentation performed using a combination of demineralized freeze-dried bone allograft layered with xenograft bone with a resorbable native collagen membrane.

Conditions

Alveolar Ridge Deficiency

Keywords

Horizontal ridge augmentation; Bone atrophy; Bone graft; Dental implant

Outcome Measures

Primary Outcomes (3)

• Amount of horizontal bone gain

  Horizontal bone gain will be measured from post operative CBCT scans taken 6-9 months following the procedure

  6-9 months

• Percentage of Vital bone

  Vital bone percentage will be measured from the bone core trephines taken 6-9 months after the procedure during implant placement

  6-9 months

• Amount of graft shrinkage

  Graft shrinkage will be measured as the change in horizontal bone width between immediate post operative CBCT scans and scans taken at 6-9 months

  6-9 months

Secondary Outcomes (1)

• Incidence of surgical complications

  1-2 weeks, 3-5 weeks, 6-8 weeks

Study Arms (1)

Xenograft and allograft

EXPERIMENTAL

The group will consist of patients receiving horizontal ridge augmentation using a combination of Demineralized Freeze Dried Bone Allograft (DFDBA) layered with xenograft particulate bone using a resorbable collagen membrane. The DFDBA will be used internally in contact with the native bone and xenograft will be layered buccal to it.

Device: Xenograft and allograft

Interventions

Xenograft and allograft DEVICE

For the guided bone augmentation procedure, a crestal incision with one or two vertical incision will be made and a full thickness mucoperiosteal flap will be elevated. Decortication will be performed and the patient will receive grafting with DFDBA with a buccal overlay of xenograft. A bi-layered native collagen membrane will be used and fixed with tacks or sutures. Periosteal incisions will be made to get tension free primary closure. The flap will be closed with sutures. Patients will be prescribed antibiotics, analgesics and mouth rinses as appropriate.

Xenograft and allograft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years of age Patients requiring horizontal bone augmentation prior to implant placement ASA I or ASA II patients Non-smoker Patients willing to be followed up for a period of 6-9 months Patients must be physically able to tolerate conventional surgical procedure or procedures under IV moderate sedation.

You may not qualify if:

• Patients with uncontrolled diabetes Patients with history of radiation to the jaw Patient with immune compromise due to disease or medication Patients requiring primarily vertical bone augmentation prior to implant placement Patients taking bisphosphonates Patients with HIV or hepatitis infection Patients who are known to be pregnant or planning to within 6 months of study enrollment Patients with a history of a failed implant in the site. Patients with an active infection or pathology in the site of treatment that need to be treated prior to bone augmentation Patients with a history of untreated generalized chronic periodontitis Patients who are unable to provide consent and require a legally authorized representative to sign on their behalf

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Geistlich Pharma: collaborator

Study Sites (1)

LSUHSC School of Dentistry

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Interventions

Transplantation, Heterologous; Transplantation, Homologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Eswar Kandaswamy, MS

  LSUHSC School of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 2, 2024
• Study Start: March 27, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)